VistaSolution — Class II medical device recall Z-2537-2020
Terminated recall by Vitalconnect Inc., reported 2020-07-15, distributed nationwide. A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should hav
| Recall number | Z-2537-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vitalconnect Inc., San Jose, CA, United States |
| Recall initiated | 2020-05-21 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 7 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00850490007139 |
| Model numbers | 6200 |
Product
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring.
Reason for recall
A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was found. A software defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2537-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.